The following data is part of a premarket notification filed by Exeter Instruments, Inc. with the FDA for Exeter Operating Loupe.
| Device ID | K863983 |
| 510k Number | K863983 |
| Device Name: | EXETER OPERATING LOUPE |
| Classification | Loupe, Binocular, Low Power |
| Applicant | EXETER INSTRUMENTS, INC. 148 BATCHELDER RD. P.O. BOX 1498 Seabrook, NH 03874 |
| Contact | David Bastable |
| Correspondent | David Bastable EXETER INSTRUMENTS, INC. 148 BATCHELDER RD. P.O. BOX 1498 Seabrook, NH 03874 |
| Product Code | HJH |
| CFR Regulation Number | 886.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1986-11-10 |